Do not take if you are pregnant. Your doctor will talk about the bad effects before starting you on this drug. Use 2 helpful kinds of birth control 1 month before starting this drug and for 1 month after care ends. Pregnancy tests will be done to show that you are NOT pregnant before starting and while taking this drug. If you get pregnant while taking this drug, call your doctor right away. If you know all the facts and can follow how to take this drug you must sign a patient fact/consent form. Do not sign the form and do not take this drug if you do not know everything on the form.

This drug is only for patients in the iPLEDGE program.

Sometimes drugs are not safe when you take them with certain other drugs. Taking them together can cause bad side effects. This is one of those drugs. Be sure to talk to your doctor about all the drugs you take.

Please read the medication guide.

Avoid

If you have an allergy to isotretinoin, vitamin A, or any other part of this drug.

Tell your doctor if you are allergic to any drugs. Make sure to tell about the allergy and what signs you had. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

If you are of childbearing age, but are not using 2 kinds of birth control or if you are planning to get pregnant during your care or within 6 months after care has ended.

If you are pregnant or may be pregnant.

If you are breast-feeding.

Precautions

Do not donate blood while using this drug and for 1 month after stopping.

If you have high blood sugar (diabetes), talk with your doctor.

If you have an eating problem, talk with your doctor.

If you have mental illness, talk with your doctor.

If you have soft, brittle bones (osteoporosis), talk with your doctor.

Have your blood work checked. Talk with your doctor.

Have a bone density test. Talk with your doctor.

Check all drugs you are taking with your doctor. This drug may not mix well with some other drugs.

Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.

Avoid other sources of vitamin A.

Limit your drinking of wine, beer, or mixed drinks.

You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.

Avoid cosmetic skin care for at least 6 months after stopping drug.

If you are a woman of childbearing age, talk with your doctor about chance of pregnancy when taking this drug. You will also get a written paper talking about the bad effects if you get pregnant.

You must have 2 pregnancy tests that show you are not pregnant. You will need a pregnancy test every month in order to get more drugs.

Use 2 kinds of birth control that you can trust 1 month before care begins, during care, and for at least 1 month after care ends.

Do not use birth control pills that have a low dose of progesterone. They may not work well.

The information in this monograph is intended for informational purposes only, and is meant to help users better understand health concerns. Information is based on review of scientific research data, historical practice patterns, and clinical experience. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions.